CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 107 enrolled
Drug / intervention
pre-operative assessment, counseling and education +11 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02687412
NCT02687412N/ACompleted

Fast-track Surgery After Gynaecological Oncological Surgery

Ling Cui·interventional·Posted Feb 22, 2016·Updated Sep 26, 2019

In Brief

A clinical study evaluating pre-operative assessment, counseling and education, Preoperative nutritional drink up to 4 h prior to surgery, and 10 other interventions for Length of Stay and 2 related conditions. Completed, enrolled 107 participants across 1 site.

Detailed Summary

Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. It has been used successfully in non-malignant gynecological surgery, but it has been proven to be especially effective in elective colorectal surgery. However, no consensus guideline has been developed for gynecological oncology surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. NO randomised controlled trials for now. The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. There is a existing research showed FTS in gynecological oncology provide early hospital discharge after gynaecological surgery meanwhile with high levels of patient satisfaction. The aim of this study is to identify patients following a FTS program who have been discharged earlier than anticipated after major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 22, 2016
Enrollment StartNov 21, 2016
Primary CompletionSep 2, 2017
Study CompletionMar 21, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.4 years ago

Interventions

pre-operative assessment, counseling and educationprocedure

pre-operative assessment, counseling and FT management education

Preoperative nutritional drink up to 4 h prior to surgeryprocedure

Preoperative nutritional drink up to 4 h prior to surgery mechanical bowl preparation should not be used

bowel preparationprocedure

patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool

preoperative treatment with carbohydratesprocedure

preoperative treatment with carbohydrates (patients without diabetes).

fast solidprocedure

fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia;

avoiding hypothermiaprocedure

avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.

Postoperative glycaemic controlprocedure

Postoperative glycaemic control;

postoperative nausea and vomiting (PONV) control;procedure

early postoperative dietprocedure

early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).

pre-operative fasting at least 8hprocedure

bowel preparation for traditional surgeryprocedure

Oral bowel preparations or mechanical bowl until liquid stool

began to take solid diet after anal exhaustprocedure

6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust